Pharmaceutical compositions usually require a suitable solvent system to solubilize or disperse the active drug component for administration to a patient. The solvent must be capable of solubilizing or dispersing a therapeutically effective amount of the active component and must be non-toxic to the patient.
Many such compositions containing paclitaxel are known but are not stable for long periods of time. U.S. Pat. No. 5,504,102 is directed to a stabilized formulation of paclitaxel that contains Cremophor EL, a condensation product of castor oil and ethylene oxide sold by BASF. U.S. Pat. No. 5,733,888 discloses another stabilized paclitaxel formulation that contains Cremophor EL. However, Cremophor EL has been implicated in causing anaphylactic reactions in some patients. Additionally, when such Cremophor EL containing formulations are admixed with aqueous parenteral infusion fluids such as 0.9% saline, the admixture is stable without precipitation for a short period of time.
Thus, it is an object of the present invention to provide a paclitaxel formulation that is stable for extended periods of time.
It is a further object of the present invention to provide a paclitaxel formulation that does not contain Cremophor EL.
It is still a further object of the present invention to provide a paclitaxel formulation that may be sterilized by terminal sterilization.
It is still a further object of the present invention to provide a paclitaxel formulation that has extended stability when admixed with pharmaceutically acceptable parenteral infusion fluids.